GovWire

What is BIA-ALCL?

In 2016, the World Health Organisation (WHO) defined a new type of anaplastic large cell lymphoma (ALCL), which is, itself, an uncommon type of non-Hodgkin lymphoma with several subtypes. The WHO labelled this new variant as breast implant associated anaplastic large cell lymphoma or BIA-ALCL*. It has specific diagnostic criteria, which include positive expression of the marker CD30, negative for ALK, and a distinct cell morphology.

The MHRAs investigation into BIA-ALCL continues and, as with all issues examined by us, we take an evidence-based approach across a range of data sources. Research into this area is yet to provide the answer as to how BIA-ALCL develops. There are several theories. One is that surface texturing on implants may play a role. There are three main surface textures which coat a breast implant; smooth, textured, and polyurethane. Research is continuing in the UK and in other countries around the world to better understand how BIA-ALCL develops.

Current UK advice

Information for patients

The most common symptom for people with BIA-ALCL around breast implants, is fluid collecting around the implant (late seroma). You might notice a fairly quick, but painless, increase in size of the affected breast, usually over a few weeks. In some cases, it can affect both sides at the same time.

Most cases have happened years after surgery. Very rarely BIA-ALCL has been found when a lump develops next to an implant, or within the tough fibrous tissue that can build up around an implant (called a capsule).

The European Commissions Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) final opinion on BIA-ALCL reports the occurrence of BIA-ALCL is uncommon. However, it is important that you know about the risks if you already have, or are considering having, breast implants. If you develop a seroma, a breast lump or swelling around your implant more than a year after having the breast implant, you should ask your implanting surgeon for advice. Also tell your GP who may need to refer you to your local NHS Breast Care service.

Before you have breast implant surgery, it is important that you talk with your surgeon to discuss the benefits and risks as part of a shared decision-making process. You should make sure that you understand the risks involved before giving your informed consent** to the treatment option that is right for you.

If you have developed a problem with a breast implant you should tell your surgeon and GP and also report it through the MHRA Yellow Card Scheme.

Information for healthcare professionals

Clinicians have a legal obligation to discuss the potential risk of BIA-ALCL when seeking informed consent of new patients, and with any patient returning for review of their breast implants.

When reporting a case of BIA-ALCL in patients with breast implants, surgeons are reminded to include (where it is known):

• the patients CD30+/-, ALK +/- status
• full details of the device, including manufacturer, model, surface texture (as identified by the manufacturer)
• the presenting clinical features and the subsequent management
• other information including the dates of initial implantation, revision, and explantation
• information on previous implants, particularly whether tissue expanders have been used and for how long

This information is vital to enable the MHRA to build a better picture of the prevalence of this issue, which contributes to the global effort to better understand this disease.

Report any suspected or actual adverse incidents involving these devices through your healthcare institutions local incident reporting system and/or your national incident reporting authority as appropriate: England, Scotland, Northern Ireland, Wales.

Please also ensure patients details are included in the Breast and Cosmetic Implant Registry (BCIR). Patient consent is no longer required for this information to be recorded and doing so will not breach General Data Protection Regulation (GDPR) rules.

Providing this information to the registry is a legal obligation under section 259(1)(a) of the Health and Social Care Act 2012.

Reports to the MHRA

Anyone can report any incident relating to a medical device or medicine to us through our Yellow Card scheme. We collect and analyse all reports ofALCLin patients with breast implants and tissue expanders. Tissue expanders are medical devices used to expand the breast tissue in preparation for breast implant surgery.

Reporting data on BIA-ALCL

• As of 31 December 2021, we had received 81 reports of confirmed BIA-ALCL where the surgery occurred in the UK and 6 reports where the surgery occurred outside of the UK.
• The current estimated incidence of BIA-ALCL, based on confirmed cases where surgery occurred in the UK, is 1 per 16,500 implants sold.

The confirmed cases have been foundin patients with breast implants that met the WHO diagnostic criteria for BIA-ALCL. The number of confirmed cases has increased by four since the last update in December 2020.

The estimated incidence is calculated by dividing the number of confirmed cases of BIA-ALCL by the number of breast implants and tissue expanders sold in the UK. It does not include BIA-ALCL cases where the surgery occurred outside of the UK. This is called an estimate because some cases of BIA-ALCL may not have been reported to the manufacturer or the MHRA, and not all implants sold in the UK have been implanted into patients.

Of the confirmed cases ofBIA-ALCLin people with breast implants in the UK, there has been one death reported to the MHRA. Two deaths from ALCL were reported to the MHRA which did not meet the WHO diagnostic criteria for BIA-ALCL. ALCL can also occur in the breast due to other causes. Therefore, the number of reports we receive may not only be related to the breast implants. However, we still need to collect reports of ALCL in people with breast implants to build up a better picture of what is happening.

The MHRA is working to deliver greater transparency of medical device data. This will ensure that both patients and clinicians are better informed on the benefits and risks associated with breast implants when deciding on the option that is right for them. Greater transparency includes providing a more detailed breakdown of the total number of confirmed reports of adverse incidents as shown below.

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